Prescription For Generic Drugs

February 27, 2006

Generic drugs are more popular than ever, credited with helping Americans save significantly on the cost of their prescriptions. Applications for new generics are on the rise, creating a logjam for the federal agency charged with screening these medicines before they are released onto the market.

Yet, strangely enough, officials for that agency, the Food and Drug Administration, say they have no plan to address the backlog.

If the FDA is unwilling to stand up for consumers, then the responsibility for a remedy falls to Congress. Lawmakers must ensure the agency has the funding and staffing needed to bring an array of generic drugs readily to market.

A generic drug gets developed when the patent for a brand-name drug expires. It has the same active ingredients and costs 60 percent to 90 percent less. Most of the time it is as effective as the brand-name drug. Consumers know a good thing when they see it; today, generics account for more than 53 percent of all prescriptions filled.

Applications to the FDA for new generic drugs are also on the rise; agency officials told members of Congress they are expecting a record number of applications this year. In December alone, the agency received 129 applications.

Yet the FDA's review isn't keeping pace. Recently, officials reported a backlog of 800 applications -- an all-time high. Worse, an FDA spokesman told Congress the agency needs no additional staffing or money, and is even contemplating cuts this year.

Last year, the FDA's Office of Generic Drugs employed about 200 people to process nearly 800 applications -- that's one employee for every four applications. By contrast, the ratio for screening new drugs in 2004 was nearly 17 FDA employees for every application.

Generic drugs provide important benefits -- and at considerably less cost to consumers and the insurance industry. By giving the FDA the resources the agency needs to help move these drugs more quickly to the market, Congress will be doing Americans a great service.